Effect of Deep Brain Stimulation (DBS) on Sleep Architecture in Patients With Movement Disorders

Parkinson's Disease Clinical Trial

Official title:

Effect of DBS on Sleep Architecture in Patients With Movement Disorders.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01169324
• Other study ID #: F100528004
• Status: Completed
• Phase: N/A
• Start date: July 15, 2010
• Est. completion date: December 11, 2015

Study information

• Verified date: April 2019
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this prospective, participant-blinded trial is to determine the changes in sleep architecture in a cohort of subjects who have undergone deep brain stimulation (DBS) surgery for treatment of movement disorders such as moderate to advanced Parkinson's disease (PD), tremor, or dystonia. Our preliminary observational data suggest that unilateral subthalamic nucleus (STN) DBS improves subjective sleep quality in PD patients 6 months after the procedure. The cause of this improvement in sleep quality is unknown, and this study proposes the use of polysomnography (PSG) to test whether the improvement in sleep is independent of improvement in night-time mobility associated with DBS treatment of the motor symptoms of PD, tremor, or dystonia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 11, 2015
• Est. primary completion date: December 11, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Prior DBS surgery for treatment of movement disorders such as PD, tremor, or dystonia.

• Stable DBS stimulator settings and medication regimen for at least 6 weeks prior to the sleep studies.

• Sleep dysfunction as measured by the Pittsburgh Sleep Quality Index (PSQI) (score >5) at the subject's baseline pre-surgical evaluation.

Exclusion Criteria:

• Known narcolepsy

• Other previous surgical treatment of Parkinson's disease, tremor, or dystonia (with the exception of DBS) including pallidotomy, thalamotomy, or gene therapy procedures.

• Untreated obstructive sleep apnea. If obstructive sleep apnea is discovered during the first sleep study, the subject will be removed from the study. After they have been treated for at least 6 weeks with CPAP, they can re-start the study.

Related Conditions & MeSH terms

• Dystonia
• Dystonic Disorders
• Movement Disorders
• Parkinson Disease
• Parkinson's Disease
• Tremor

Intervention

Other:
• Alteration of DBS stimulator settings
Alteration of DBS stimulator settings

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep Efficiency	This is the percentage of time the subject is in bed when he/she is actually asleep.	1 month
Secondary	Wake after sleep onset (WASO)	This is a measurement of the amount of time during polysomnography recording that the subject is awake after their initial sleep onset.	1 month
Secondary	Total Sleep Time		1 month
Secondary	Two timed motor tasks	The subject will tap index finger between 2 points 30 cm apart on the table for 10 seconds.; The subject will be timed as they rise from a chair, walk 7 meters, return to the chair, and sit down.	1 month